You can't get more TL;DR (too long; didn't read, for the non-millenials in the audience) than this document from the CBER and the FDA, but there is so much important stuff in here it can't be ignored.
Here are some of the highlights:
- The new Mutual Recognition Agreement allows for EU regulators to conduct inspections which will be approved by the FDA and vise versa. https://www.fda.gov/InternationalPrograms/Agreements/ucm598735.htm
- In the world of Gene Therapy, the FDA has released new guidelines for the approval of CMC sections in an IND application. http://bit.ly/2ISBu1M
- And a very interesting guidance document on the implementation of Adaptive Clinical Study Design. http://bit.ly/2IWfHWY
There is a lot to digest here, but it will be time well-spent.
Is there any area where you think the FDA is falling behind? They clearly are trying to be proactive, but they are still going to move at the speed of bureaucracy. What are they missing?